U.S. patent application number 16/573606 was filed with the patent office on 2020-01-09 for wearable cardiac monitor.
This patent application is currently assigned to RHYTHM DIAGNOSTIC SYSTEMS, INC.. The applicant listed for this patent is RHYTHM DIAGNOSTIC SYSTEMS, INC.. Invention is credited to Sam Eletr, George Stefan Golda, Mark P. Marriott, Daniel Van Zandt Moyer, Bruce O'Neil.
Application Number | 20200008749 16/573606 |
Document ID | / |
Family ID | 50433219 |
Filed Date | 2020-01-09 |
View All Diagrams
United States Patent
Application |
20200008749 |
Kind Code |
A1 |
Golda; George Stefan ; et
al. |
January 9, 2020 |
WEARABLE CARDIAC MONITOR
Abstract
Systems, methods and devices for reducing noise in cardiac
monitoring including wearable monitoring devices having at least
one electrode for cardiac monitoring; in some implementations, the
wearable device using a composite adhesive having at least one
conductive portion applied adjacent the electrode; and, in some
implementations, including circuitry adaptations for the at least
one electrode to act as a proxy driven right leg electrode.
Inventors: |
Golda; George Stefan; (El
Granada, CA) ; Moyer; Daniel Van Zandt; (Menlo Park,
CA) ; Marriott; Mark P.; (Palo Alto, CA) ;
Eletr; Sam; (Paris, FR) ; O'Neil; Bruce; (San
Francisco, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
RHYTHM DIAGNOSTIC SYSTEMS, INC. |
SAN FRANCISCO |
CA |
US |
|
|
Assignee: |
RHYTHM DIAGNOSTIC SYSTEMS,
INC.
SAN FRANCISCO
CA
|
Family ID: |
50433219 |
Appl. No.: |
16/573606 |
Filed: |
September 17, 2019 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
13837748 |
Mar 15, 2013 |
10413251 |
|
|
16573606 |
|
|
|
|
61710768 |
Oct 7, 2012 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/04085 20130101;
A61B 5/0205 20130101; A61B 5/14551 20130101; A61B 2560/0295
20130101; A61B 5/7207 20130101; A61B 5/14552 20130101; A61B 5/0261
20130101; A61B 5/02141 20130101; A61B 5/0402 20130101; A61B 5/0295
20130101; A61B 5/0059 20130101; A61B 5/7214 20130101; A61B 5/04325
20130101; A61B 5/6833 20130101; A61B 5/0002 20130101; A61B 5/02438
20130101; A61B 2560/0412 20130101; A61B 5/72 20130101; A61B 5/0006
20130101; A61B 5/11 20130101; A61B 5/721 20130101; A61B 5/1118
20130101; A61B 5/6828 20130101; A61B 5/04087 20130101; A61B 5/02125
20130101; A61B 5/0456 20130101; A61B 5/7275 20130101; A61B 5/08
20130101 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61B 5/0432 20060101 A61B005/0432; A61B 5/0205 20060101
A61B005/0205; A61B 5/026 20060101 A61B005/026; A61B 5/0295 20060101
A61B005/0295; A61B 5/0408 20060101 A61B005/0408; A61B 5/11 20060101
A61B005/11; A61B 5/0402 20060101 A61B005/0402; A61B 5/08 20060101
A61B005/08; A61B 5/021 20060101 A61B005/021 |
Claims
1. A device for monitoring a physiological parameter, the device
being adapted to be adhered to the skin of a subject for the
physiological parameter monitoring; the device comprising: a
substrate; a conductive sensor connected to the substrate, and a
double-sided composite adhesive having: at least one conductive
adhesive portion, and at least one non-conductive adhesive portion;
the double-sided composite adhesive being attached to the substrate
and the conductive sensor; the at least one conductive adhesive
portion being disposed in conductive communicative contact with the
conductive sensor and being adapted to be conductively adhered to
the skin of the subject for conductive signal communication from
the subject to the conductive sensor.
2. A device according to claim 1 wherein conductive adhesive
portion of the composite adhesive is connected to respective sensor
and adapted to be substantially securely connected to the skin to
maintain the respective sensor substantially fixed relative to the
skin and thereby one or both reduce or eliminate possible sensor
movement relative to the skin.
3. A device according to claim 2 wherein the connection of the
conductive adhesive portion to the respective sensor and to the
skin removes movement of the sensor relative to the skin which
removes noise which provides a clean signal.
4. A device according to claim 1 wherein the physiological
parameter includes one or more signals for one or more or all of
electrocardiography, photoplethysmography, pulse oximetry or
subject acceleration.
5. A device according to claim 4 wherein the conductive sensor is
an electrode for electrocardiography.
6. A device according to claim 5 wherein the electrode is a proxy
driven-right-leg electrode.
7. A device according to claim 1 comprising a plurality of
conductive sensors connected to the substrate, the composite
adhesive having a plurality of conductive adhesive portions, the
plurality of conductive adhesive portions being disposed in
conductive communicative contact with respective ones of the
plurality of conductive sensors, and being adapted to be
conductively adhered to the skin of the subject for conductive
signal communication from the subject to the conductive sensor.
8. A device according to claim 7 wherein the plurality of
conductive sensors include at least one, two or three electrodes
for electrocardiography.
9. A device according to claim 8 wherein one of the electrodes is a
proxy driven-right-leg electrode.
10. A device according to claim 1 which is adapted to provide one
or both of collected data or analysis to a receiving system
component.
11. A device according to claim 10 wherein the one or both of
collected data and analysis are transmitted by one or both of
wireless or wired connections.
12. A system including a device according to claim 10 wherein the
receiving system component is a computing device.
13. A system for collecting and analyzing physiological data
corresponding to physiological signals of a subject; the system
comprising: a wearable device for collecting physiological data
from a subject and one or both of transmitting and analyzing the
physiological data; and, a receiving system component for receiving
physiological data transmitted by the device.
14. A system according to claim 13 wherein the wearable device
comprises on-board memory for storing collected data.
15. A system according to claim 13 wherein the receiving system
component is a computing device adapted to analyze data received
from the wearable device.
16. A system according to claim 13 wherein the wearable device has
at least one electrode and a composite adhesive, the composite
adhesive having at least one conductive adhesive portion in
communication with the at least one electrode.
17. A system according to claim 13 wherein the wearable device has
at least one electrode and circuitry for the at least one electrode
to function as a proxy driven-right-leg electrode.
18. A method for reducing noise in cardiac monitoring using a
wearable monitoring device having at least one electrode for
cardiac monitoring; the method comprising: applying the wearable
monitoring device to a subject; including one or both of: using a
composite adhesive having at least one conductive portion; or,
using circuitry adaptations for the at least one electrode to act
as a proxy driven-right-leg electrode; collecting data
representative of physiological signals; analyzing the data.
19. A method according to claim 18 further comprising: transmitting
the data from the wearable device.
20. A method according to claim 18 further comprising; transmitting
the data from the wearable device; and, storing the data prior to
one or both of transmitting or analyzing the data.
21. A circuit for mimicking a right leg electrode using a chest
reference electrode as proxy therefor; the circuit comprising: a
connection to a first electrocardiogram electrode; a connection to
a second electrocardiogram electrode; a connection to a reference
electrocardiogram electrode; and, an amplifier; the electrode
connections all connected to the amplifier; the amplifier
maintaining the voltage of the first and second electrodes level,
the proxy driven right leg signal being measurable using the
reference electrode.
22. A circuit for mimicking a right leg electrode using a chest
reference electrode as proxy therefor; the circuit comprising: a
connection to a sense electrode; a connection to a drive electrode;
a bias voltage input; and, an amplifier; the electrode connections
and bias voltage input connected to the amplifier; the amplifier
output connected to the drive electrode, the inverting input to the
sense electrode, and the non-inverting input to a bias voltage; the
amplifier maintaining the voltage of the sense electrode at a level
close to the bias voltage; the proxy driven right leg signal being
measurable using a third electrode.
23. A device for monitoring physiological parameters of a patient
comprising: a flexible circuit embedded in a flat elastic substrate
having a top surface and a bottom surface, the flexible circuit
having (i) at least one sensor mounted in the bottom surface of the
flat elastic substrate, the at least one sensor being capable of
electrical or optical communication with the patient, (ii) at least
one signal processing module for accepting signals from the at
least one sensor and transforming such signals for storage as
patient data; (iii) at least one memory module for accepting and
storing patient data, (iv) at least one data communication module
for transferring stored patient data to an external device, and (v)
a control module for controlling the timing and operation of the at
least one sensor, the at least one signal processing module, the at
least one memory module, and the at least one data communication
module, the control module capable of receiving commands to
implement transfer of patient data by the at least one data
communication module and to erase and/or wipe patient data from the
at least one memory module; and an anisotropically conductive
adhesive removably attached to the bottom surface of the flat
elastic substrate, the anisotropically conductive adhesive capable
of adhering to skin of the patient and of conducting an electrical
signal substantially only in a direction perpendicular to the
bottom surface of the flat elastic substrate.
24. The device of 23 wherein said at least one sensor includes an
electrode for measuring electrical signals from said patient's
heart and an optical blood oxygen sensor.
25. The device of 23 wherein said at least one data communication
module is capable of transmitting said patient data by wireless
signals to an external device.
26. The device of 25 wherein said external device receiving said
patient data is a signal relay device.
27. The device of 23 wherein said flexible circuit is capable of
being powered wirelessly.
28. The device of 23 wherein said at least one signal processing
module receives a signal from at least one electrode from measuring
electrical signals from said patient's heart and a signal from a
driven right leg circuit for reducing common mode noise from said
patient data.
29. A system for monitoring physiological parameters of a patient
comprising: a flexible circuit embedded in a flat elastic substrate
having a top surface and a bottom surface, the flexible circuit
having (i) at least one sensor mounted in the bottom surface of the
flat elastic substrate, the at least one sensor being capable of
electrical or optical communication with the patient, (ii) at least
one signal processing module for accepting signals from the at
least one sensor and transforming such signals for storage as
patient data; (iii) at least one memory module for accepting and
storing patient data, (iv) at least one data communication module
for transferring stored patient data to an external device, and (v)
a control module for controlling the timing and operation of the at
least one sensor, the at least one signal processing module, the at
least one memory module, and the at least one data communication
module, the control module capable of receiving commands to
implement transfer of patient data by the at least one data
communication module and to erase and/or wipe patient data from the
at least one memory module; an anisotropically conductive adhesive
removably attached to the bottom surface of the flat elastic
substrate, the anisotropically conductive adhesive capable of
adhering to skin of the patient and of conducting an electrical
signal substantially only in a direction perpendicular to the
bottom surface of the flat elastic substrate; and a computer for
accepting patient data from said data communication module and for
displaying the patient data and/or for generating an alert if
values of patient data exceed predetermined limits.
Description
CROSS-REFERENCE TO RELATED APPLICATION(S)
[0001] This is a nonprovisional application claiming the benefit of
and priority to the provisional application, U.S. 61/710,768 filed
Oct. 7, 2012, the entire contents, teachings and suggestions
thereof being incorporated herein by this reference as if fully set
forth here.
BACKGROUND
[0002] Advances in electronics, sensor technology and materials
science have revolutionized patient monitoring technologies. In
particular, many light and wearable devices are becoming available
for a variety of cardiac monitoring applications. However,
improvements may yet be desired for robust wearable devices that
provide effective data collection, in some cases also with
increased patient convenience and comfort. Other alternatives may
include developments in one or more of device attachment, size,
flexibility, data transfer, among others.
[0003] Further alternatives for cardiac patients and their
physicians may then include robust and convenient personal cardiac
monitors that in some instances may collect and transfer long-term
data as well as monitor events in real-time.
SUMMARY
[0004] Described herein are several medical monitoring devices and
systems, in some instances for long-term sensing and/or recording
of cardiac patient data. A number of alternative implementations
and applications are summarized and/or exemplified herein below and
throughout this specification.
[0005] These as well as other aspects are exemplified in a number
of illustrated alternative implementations and applications, some
of which are shown in the figures and characterized in the claims
section that follows. However, as will be understood by the
ordinarily skilled artisan, the above summary and the detailed
description below do not describe the entire scope of the
inventions hereof and are indeed not intended to describe each
illustrated embodiment or every implementation of the present
inventions nor provide any limitation on the claims or scope of
protection herein set forth below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] The drawings include:
[0007] FIG. 1, which includes sub-part FIGS. 1A-1G, illustrates
several alternatives of the present inventions, including various
of isometric, top and bottom plan and elevational views of devices
and alternative conductive adhesive structures.
[0008] FIG. 2, which includes sub-part FIGS. 2A-2C, provides
circuit diagrams of alternatives to a driven right leg circuit.
[0009] FIG. 3 is a flow chart including alternative methods of
use.
[0010] FIG. 4 illustrates an exemplary computer system or computing
resources with which implementations hereof may be utilized.
[0011] FIG. 5, which includes sub-part FIGS. 5A-5D, provides
alternative screenshots of alternative software implementations
according hereto.
DETAILED DESCRIPTION
[0012] While the inventions hereof amenable to various
modifications and alternative forms, specifics thereof have been
shown by way of example in the drawings and the following
description. It should be understood, however, that the intention
is not to limit the invention to the particular embodiments
described. The intention is to cover all modifications,
equivalents, and alternatives falling within the spirit and scope
of the invention whether described here or otherwise being
sufficiently appreciable as included herewithin even if beyond the
literal words hereof.
[0013] In one aspect, a system hereof may include a device for
monitoring physiological parameters such as one or more or all of
electrocardiogram (aka ECG or EKG), photoplethysmogram (aka PPG),
pulse oximetry and/or patient acceleration or movement signals.
Systems hereof may be established to measure and process such
signals of a patient using or including one or more of the
following elements: (a) a circuit, sometimes flexible, embedded in
a flat elastic substrate having a top surface and a bottom surface,
the circuit having (i) at least one sensor mounted in or adjacent
the bottom surface of the flat elastic substrate, the at least one
sensor being capable of electrical or optical communication with
the patient, (ii) at least one signal processing module for
receiving and/or accepting signals from the at least one sensor in
some implementations also providing for transforming such signals
for storage as patient data; (iii) at least one memory module for
receiving and/or accepting and storing patient data, (iv) at least
one data communication module for transferring stored patient data
to an external device, and (v) a control module for controlling the
timing and operation of the at least one sensor, one or more of the
at least one signal processing module, the at least one memory
module, the at least one data communication module, and/or the
control module capable of receiving commands to implement transfer
of patient data by the at least one data communication module and
to erase and/or wipe patient data from the at least one memory
module; and (b) a anisotropically conductive adhesive removably
attached to the bottom surface of the flat elastic substrate, the
anisotropically conductive adhesive capable of adhering to skin of
the patient and of conducting an electrical signal substantially
only in a direction perpendicular to the bottom surface of the flat
elastic substrate, and/or in some implementations including a
conductive portion adjacent the sensor or sensors and a
non-conductive portion.
[0014] In some implementations, devices hereof will be for
comprehensive long-term cardiac monitoring. Features of such may
include one or more of a Lead 1 ECG, PPG, pulse oximeter,
accelerometer, and a button or other indicator for manual patient
event marking Such a device may be adapted to store up to, for
example, about two weeks of continuous data (though more will also
be feasible in alternative implementations), which may in some
implementations be downloaded to a clinic or other computer in a
short time period, as for one example, in only about 90 seconds
(though less time will be viable in alternative implementations)
via computer connection, whether wireless or wired as in one
example by USB or other acceptable data connection. A companion
software data analysis package may be adapted to provide automated
event capture and/or allow immediate, local data
interpretation.
[0015] Intermittent cardiac anomalies are often difficult for
physicians to detect and/or diagnose, as they would typically have
to occur during a physical examination of the patient. A device
hereof may address this problem with what in some implementations
may be a continuous or substantially continuous monitoring of a
number of vital signs.
[0016] Some alternative features may include (i) a driven "Right
Leg" circuit with electrodes located only on the chest, (ii) a
"z-Axis" or anisotropic conductive adhesive electrode interface
that may permit electrical communication only between an electrode
and a patient's skin immediately beneath the electrode, (iii) data
transmission to and interpretation by a local computer accessible
to CCU/ICU personnel, (iv) a unique combination of hardware allows
correlation of multiple data sources in time concordance to aid in
diagnosis.
[0017] In some alternative implementations, devices and systems
hereof may provide 1) reusability (in some cases near or greater
than about 1000 patients) allows recouping cost of the device in
just about 10-15 patient tests, 2) one or more of ecg waveform
data, inertial exertion sensing, manual event marking, and/or pulse
oximeter, any or all of which in time concordance to better detect
and analyze arrhythmic events, 3) efficient watertightness or
waterproofing (the patient can even swim while wearing the device),
and 4) a comprehensive analysis package for immediate, local data
interpretation. An alternative device may be adapted to take
advantage of flex-circuit technology, to provide a device that is
light-weight, thin, durable, and flexible to conform to the
patient's skin.
[0018] FIGS. 1 and 2 illustrate examples of alternative
implementations of devices that may be so adapted.
[0019] FIG. 1 shows a device 100 that has a component side or top
side 101, patient side or circuit side 102, and one or more inner
electrical layer(s), generally identified by the reference 103 and
an elongated strip layer 105. The strip layer 105 may have
electronics thereon and/or therewithin. FIG. 1A shows isometrically
these together with some other elements that may be used herewith.
FIG. 1B is more specifically directed to a top side 101 plan view
and FIG. 1C to an underside, patient side 102 plan view and FIG. 1D
a first elevational, side view.
[0020] Many of the electronics hereof may be disposed in the
electronics layer or layers 103, and as generally indicated here,
the electronics may be encapsulated in a material 104 (see FIGS.
1A, 1B and 1D for some examples), plastic or the like, or potting
material, to fix them in operative position on or in or otherwise
functionally disposed relative to the elongated strip layer 105.
The potting or other material may in many implementations also or
alternatively provide a waterproof or watertight or water resistant
coverage of the electronics to keep them operative even in water or
sweat usage environments. One or more access points, junctions or
other functional units 106 may be provided on and/or through any
side of the encapsulation material 104 for exterior access and/or
communication with the electronics disposed therewithin, or
thereunder. FIGS. 1A, 1B and 1D show four such accesses 106 on the
top side. These may include high Z data communication ports and/or
charging contacts, inter alia. This upper or component side 101 of
device 100 may be coated in a silicone compound for protection
and/or waterproofing, with only, in some examples, a HS USB
connector exposed via one or more ports 106, e.g., for data
communication or transfer and/or for charging.
[0021] The elongated strip layer 105 may be or may include a
circuit or circuit portions such as electrical leads or other inner
layer conductors, e.g., leads 107 shown in FIG. 1D, for
communication between the electronics 103 and the electrically
conductive pads or contacts 108, 109 and 110 described further
below (108 and 109 being in some examples, high impedance/high Z
silver or copper/silver electrodes for electrocardiograph, ECG, and
110 at times being a reference electrode). In many implementations,
the strip layer 105 may be or may include flex circuitry understood
to provide acceptable deformation, twisting, bending and the like,
and yet retain robust electrical circuitry connections therewithin.
Note, though the electronics 103 and electrodes 108, 109, 110 are
shown attached to layer 105; on top for electronics 103, and to the
bottom or patient side for electrodes 108, 109, 110; it may be that
such elements may be formed in or otherwise disposed within the
layer 105, or at least be relatively indistinguishably disposed in
relative operational positions in one or more layers with or
adjacent layer 105 in practice. Similarly, the leads or traces 107
are shown embedded (by dashed line representation in FIG. 1D);
however, these may be on the top or bottom side, though more likely
top side to insulate from other skin side electrical
communications. If initially top side (or bottom), the traces may
be subsequently covered with an insulative encapsulant or like
protective cover (not separately shown), in many implementations, a
flexible material to maintain a flexible alternative for the
entire, or majority of layer 105.
[0022] On the patient side 102, the ECG electrodes 108, 109 and 110
may be left exposed for substantially direct patient skin contact
(though likely with at least a conductive gel applied
therebetween); and/or, in many implementations, the patient side
electrodes 108, 109 and/or 110 may be covered by a conductive
adhesive material as will be described below. The electrodes may be
or may be may be plated with a robust high conductive material, as
for example, silver/silver chloride for biocompatibility and high
signal quality, and in some implementations may be highly robust
and, for one non-limiting example, be adapted to withstand over
about 1000 alcohol cleaning cycles between patients. Windows or
other communication channels or openings 111, 112 may be provided
for a pulse oximeter, for example, for LEDs and a sensor. Such
openings 111, 112 would typically be disposed for optimum light
communication to and from the patient skin. An alternative
disposition of one or more light conduits 111a/112a is shown in a
non-limiting example in FIG. 1D more nearly disposed and/or
connected to the electronics 103. A variety of alternative
placements may be usable herein/herewith.
[0023] FIG. 1D provides a first example of an adhesive 113 that may
be used herewith. The adhesive layer 113 is here a double-sided
adhesive for application to the bottom side 102 of the device 100,
and a second side, perhaps with a different type of adhesive for
adhering to the skin of the human patient (not shown). Different
types of materials for adhesion might be used in that the material
of choice to which the adhesive layer is to be attached are
different; typically, circuit or circuit board material for
connection to the device 100, and patient skin (not separately
shown) on the patient side. A protective backing 114 may be
employed on the patient side until application to the patient is
desired. Note, in many applications, the adhesive 113 is
anisotropic in that it may preferably be only conductive in a
single or substantially a single direction, e.g., the axis
perpendicular to the surface of adhesive contact. Thus, good
electrically conductive contact for signal communication can be had
through such adhesive to/through the adhesive to the electrical
contacts or electrodes, 108, 109 and 110. Note, a corresponding one
or more light apertures 111b/112b are shown in the adhesive of 113
of the example of FIG. 1D to communicate light therethrough in
cooperation with the light conduit(s) 111a/112a in/through layer
105 for communication of light data typically involved in pulse
oximetry.
[0024] The adhesive may thus be placed or disposed on the device
100, in some implementations substantially permanently, or with
some replaceability. In some implementations, the device as shown
in FIGS. 1A-1D and/or 1G without (or with in some implementations)
the adhesive may be reusable. In many such cases, the adhesive
layer 113 may be removed and replaced before each subsequent use,
though subsequent re-use of and with a layer 113 is not foreclosed.
In a first or subsequent use with a replaceable adhesive layer 113,
it may be that the user applying the device to the patient, e.g.,
the physician or technician or even the patient, him/herself,
applies the conductive transfer adhesive 113 to the patient side
102 of the device 100. The protective backing 114 may then be
removed, and the device adhered to the patient and activated.
Activation may occur in a number of ways; in some, it may be
pre-set that an affirmative activation interaction may not be
necessary from the doctor or patient or like due to either an
inertial and/or a pulse oximeter activation which may be
substantially automatically activating, e.g., upon receiving
sufficient minimum input (movement in case of inertial system or
light reflection of blood flow for pulse oximetry); however, a
button may be provided at access 106 or in some other location
adjacent the electronics to allow the patient to start or stop the
device or otherwise mark an event if desired. In one exemplar
implementation the device may be worn for a period such as two
weeks for collection of data substantially continuously, or at
intervals as may be preferred and established in or by the systems
hereof.
[0025] After a monitoring period is over a physician, technician,
patient or other person may then remove the device from the patient
body, remove the adhesive, in some instances with alcohol, and may
establish a data communication connection for data transfer, e.g.,
by wireless communication or by insertion/connection of a USB or
like data connector to download the data. The data may then be
processed and/or interpreted and in many instances, interpreted
immediately if desired. A power source on board may include a
battery and this can then also be re-charged between uses, in some
implementations, fully recharged quickly as within about 24 hours,
after which the device could then be considered ready for the next
patient.
[0026] Some alternative conductive adhesives may be used herewith.
FIGS. 1E, 1F and 1G show one such alternative conductive adhesive
113a; a bottom plan view in FIG. 1E and elevational side views
thereof in FIGS. 1F and 1G (as being connected to a device 100 in
FIG. 1G). In some implementations, the conductivity may be
anisotropic as introduced above; in some conductive primarily if
not entirely in the direction of the Z-Axis; perpendicular to the
page (into and/or out of the page) in FIG. 1E, and/or vertically or
transversally relative to the long horizontal shown axis of device
100 in the implementation view of FIG. 1F.
[0027] The implementation of this particular example includes a
composite adhesive 113a which itself may include some
non-conductive portion(s) 113b and some one or more conductive
portions 113c. The adhesive composite 113a may, as described for
adhesive 113 above be double sided such that one side adheres to
the patient while the other side would adhere to the underside 102
of the device 100 (see FIG. 1G) so that one or more conductive
portions 113c may be disposed or placed in electrically
communicative and/or conductive contact with the integrated
electrodes on the electronic monitoring device 100. Since the
electrodes would operate better where they may be electrically
isolated or insulated from each other, yet each making electrical
contact or communication with the patient's skin, the adhesive may
further be more specifically disposed in some implementations as
follows.
[0028] As shown in FIGS. 1E and 1F, three isolated conductive
portions 113c may be disposed separated from each other by a body
portion 113b which may be non-conductive. These could then
correspond to the electrodes 108, 109, 110 from the above-described
examples, and as more particularly shown schematically in FIG. 1G
(note the scale is exaggerated for the adhesive 113a and thus,
exact matching to the electrodes of device 100 is not necessarily
shown). In some examples, the electrode areas 113c may be a
conductive hydrogel that may or may not be adhesive, and in some
examples, may be made of a conductive an adhesive conductive
material such as 3M Corporation 9880 Hydrogel adhesive (3M Company,
St. Paul, Minn.). These areas 113c may then be isolated from each
other by a non-conductive material 113b such as 3M Corporation 9836
tape or 3M double-sided Transfer Adhesive 9917 (3M, St. Paul,
Minn.) or equivalent. The additional layer 113d, if used, might be
a 3M 9917 adhesive together with the 113b of a 9836 material. These
constructs may provide the effect of creating a low electrical
impedance path in the Z-axis direction (perpendicular to page for
FIG. 1E and vertically/transversally for FIGS. 1F and 1G) for the
electrode areas 113c, and high electrical impedance path between
the electrodes in the X/Y directions. (See FIGS. 1E, 1F and 1G;
coplanar with the page in FIG. 1E and horizontal and perpendicular
to the page in FIGS. 1F and 1G). Thus, a composite adhesive strip
can ensure not only device adhering to the patient, but also that
the electrodes whether two or as shown three electrodes are
conductively connected by conductive portions of the adhesive
strip, where the combination of conductive and non-conductive
portions can then reduce signal noise and/or enhance noise free
characteristics. Electrodes that move relative to skin can
introduce noise. I.e., electrodes electrically
communicative/connected to the skin via a gel may move relative to
the skin and thus introduce noise. However, with one or more
conductive adhesive portions in a composite adhesive connected to
respective electrodes and then substantially securely connected to
the skin will keep the respective electrodes substantially fixed
relative to the skin and thereby reduce or even eliminate electrode
movement relative to the skin. Removal of such movement would then
remove noise which would thereby provide a clean signal that can
allow for monitoring cardiac P waves which enhances the possibility
to detect arrythmias that couldn't otherwise be detected. Further
description is set forth below.
[0029] In some implementations, a further optional connective
and/or insulative structure 113d may be implemented as shown in
FIG. 113d to provide further structural and insulative separation
between electrodes with connected to a device 100 on the underside
102 thereof (see FIG. 1G). Though shown separate in FIGS. 1F and
1G, it may be contiguous with the insulative adhesive 113b of these
views.
[0030] Some alternative implementations hereof may include a driven
right leg ECG circuit with one or more chest only electrodes
("Driven Chest Electrode"). In addition to the electrodes used to
measure a single or multiple lead electrocardiogram signal, a
device 100 may use an additional electrode, as for example the
reference electrode 110 (see FIGS. 1A, 1C, 1D and 1G, e.g.) to
reduce common mode noise. Such an electrode may function in a
manner similar to the commonly-used driven right leg electrode, but
may here be located on the patient's chest rather than on the
patient's right leg but nevertheless this third/reference electrode
may play the role of the leg electrode. This chest electrode may
thus mimic a right leg electrode and/or be considered a proxy
driven right leg electrode. A circuit, or portion of an overall
circuit, adapted to operate in this fashion may include a number of
amplifier stages to provide gain, as well as filtering to ensure
circuit stability and to shape the overall frequency response. Such
a circuit may be biased to control the common mode bias of the
electrocardiogram signal. This driven chest electrode
implementation may be used in conjunction with a differential or
instrumentation amplifier to reduce common mode noise. In this
case, the sense electrode may be used as one of the
electrocardiogram electrodes. Alternatively, a single-ended
electrocardiogram amplifier may be used where the differential
electrocardiogram signal is referenced to ground or to some other
known voltage.
[0031] A circuit or sub-circuit 200 using a transistor 201 as shown
in FIG. 2 may be such a circuit (aka module) and may thus include
as further shown in FIG. 2A, a sense electrode 202, a drive
electrode 203, and an amplifier 204. Both the sense and drive
electrodes 202, 203 are placed on the patient's chest such that
they provide an electrical connection to the patient. The amplifier
204 may include gain and filtering. The amplifier output is
connected to the drive electrode, the inverting input to the sense
electrode, and the non-inverting input to a bias voltage 205. The
amplifier maintains the voltage of the sense electrode at a level
close to the bias voltage. An electrocardiogram signal may then be
measured using additional electrodes. Indeed, as was the case for
the improved conductivity through use of anisotropic adhesive
portions above, here also or alternatively, the use of this third
electrode as a proxy for a right leg electrode (i.e., proxy driven
right leg electrode) can provide signal reception otherwise
unavailable. Clean signals may thus allow for receiving cardiac P
waves which enhances the possibility to detect arrythmias that
couldn't otherwise be detected.
[0032] Further alternative descriptions of circuitry include that
which is shown in FIGS. 2B and 2C; in which are shown non-limiting
alternatives in which three adjacent electrodes E1, E2, and E3 may
be used to pick up the ECG signal, one of which electrodes playing
the role of the distant limb electrode of traditional ECG monitors.
Because the electrode-patient interface has an associated impedance
(Re1 and Re2), current flowing through this interface will cause a
difference in voltage between the patient and the electrode. The
circuit may use a sense electrode (E1) to detect the patient
voltage. Because this exemplar circuit node has a high impedance to
circuit ground (GND), very little current flows through the
electrode interface, so that the voltage drop between the patient
and this node is minimized. The first of these alternative,
non-limiting circuits (FIG. 2B) also contains an amplifier (U1)
whose low-impedance output is connected to a separate drive
electrode (E2). The amplifier uses negative feedback to control the
drive electrode such that the patient voltage (as measured by the
sense electrode E1) is equal to the bias voltage (V1). This may
effectively maintain the patient voltage equal to the bias voltage
despite any voltage difference between the driven electrode (E2)
and the patient. This can include voltage differences caused by
power line-induced current flowing between the drive electrode and
the patient (through Re2). This arrangement differs from a
traditional `driven-right-leg` circuit in at least two ways: the
driven electrode is placed on the patient's chest (rather than the
right leg), and the ECG signal is a single-ended (not differential)
measurement taken from a third electrode (E3). Because all
electrodes are located on the patient's chest, a small device
placed there may contain all the necessary electrodes for ECG
measurement. One possible benefit of the single-ended measurement
is that gain and filtering circuitry (U2 and associated components
(FIG. 2C)) necessary to condition the ECG signal prior to recording
(ECG Output) requires fewer components and may be less sensitive to
component tolerance matching. The examples of FIGS. 2A, 2B and 2C
are non-limiting examples and not intended to limit the scope of
the claims hereto as other circuits with other circuit elements can
be formed by skilled artisans in view hereof and yet remain within
the spirit and scope of claims hereof.
[0033] In many implementations, a system hereof may include other
circuitry operative together with the ECG electrodes, which may
thus be accompanied by other sensors to provide time concordant
traces of: i) ECG p-, qrs-, and t-waves; ii) O2 Saturation, as
measured by Pulse Oxymetry; and/or iii) xyz acceleration, to
provide an index of physical activity. Such circuitry may be
implemented to one or more of the following electrical
specifications. The overall system might in some implementations
include as much as two weeks (or more) of continuous run time;
gathering data during such time. Some implementations may be
adapted to provide as many or even greater than 1000 uses.
Alternatives may include operability even after or during exposure
to fluids or wetness; in some such examples being water resistant,
or waterproof, or watertight, in some cases continuing to be fully
operable when fully submerged (in low saline water). Other
implementations may include fast data transfer, as for an example
where using an HS USB for full data transfer in less than about 90
seconds. A rechargeable battery may typically be used.
[0034] A further alternative implementation may include an
electronic "ground": In a device hereof, mounted entirely on a
flexible circuit board, the ground plane function may be provided
by coaxial ground leads adjacent to the signal leads. The main
contribution of this type of grounding system may be hat it may
allow the device the flexibility required to conform and adhere to
the skin.
[0035] For electrocardiograph; EKG or ECG, some implementations may
include greater than about 10 Meg Ohms input impedance; some
implementations may operate with a 0.1-48 Hz bandwidth; and some
with an approximate 256 Hz Sampling Rate; and may be implementing
12 Bit Resolution. For PPG and Pulse Oximeter, operation may be
with 660 and 940 nm Wavelength; about 80-100 SpO2 Range; a 0.05-4.8
Hz Bandwidth; a 16 Hz Sampling Rate; and 12 bit resolution. For an
accelerometer: a 3-Axis Measurement may be employed, and in some
implementations using a .+-.2 G Range; with a 16 Hz Sampling Rate;
and a 12 Bit Resolution.
[0036] Some summary methodologies may now be understood with
relation to FIG. 3, though others may be understood through and as
parts of the remainder of the disclosure hereof. A flow chart 300
as in FIG. 3 may demonstrate some of the alternatives; where an
initial maneuver 301 might be the application of the device 100 to
the patient. Indeed, this might include some one or more of the
alternatives for adhesive application as described here above,
whether by/through use of an adhesive such as that 113 of FIG. 1D,
or that of FIGS. 1E, 1F and/or 1G. Then, as shown, in moving by
flow line 311, a data collection operation 302 may be implemented.
Note, this might include a continuous or substantially continuous
collection or an interval or periodic collection or perhaps even a
one time event collection. This may depend upon the type of data to
be collected and/or be dependent upon other features or
alternatives, as for example whether a long term quantity of data
is desired, for ECG for example, or whether for example a relative
single data point might be useful, as in some cases of pulse
oximetry (sometimes a single saturation point might be of interest,
as for example, if clearly too low, though comparison data showing
trending over time, may indeed be more typical).
[0037] Several alternatives then present in FIG. 3, flow chart 300;
a first such might be the following of flowline 312 to the
transmission of data operation 303, which could then involve either
wireless or wired (e.g., USB or other) data communication from the
device 100 to data analysis and/or storage devices and/or systems
(not separately shown in FIG. 3; could include computing devices,
see e.g., FIG. 4 described below, or the like). Options from this
point also appear; however, a first such might include following
flow line 313 to the data analysis operation 304 for analyzing the
data for determination of the relative health and/or for condition
diagnosis of a patient. Computing systems, e.g., a computer (could
be of many types, whether hand-held, personal or mainframe or
other; see FIG. 4 and description below) could be used for this
analysis; however, it could be that sufficient intelligence might
be incorporated within the electronics 103 of device 100 such that
some analysis might be operable on or within device 100 itself. A
non-limiting example, might be a threshold comparison, as for
example relative to pulse oximetry where when a low (or in some
examples, perhaps a high) threshold level is reached an indicator
or alarm might be activated all on/by the electronics 103 of the
device 100.
[0038] A similar such example, might be considered by the optional
alternative flow path 312a which itself branches into parts 312b
and 312c. Following flow path 312a, and then, in a first example
path 312b, a skip of the transmit data operation 303 can be
understood whereby analysis 304 might be achieved without
substantial data transfer. This could explain on board analysis,
whether as for example according to the threshold example above, or
might in some instances include more detailed analysis depending
upon how much intelligence is incorporated on/in the electronics
103. Another view, is relative to how much transmission may be
involved even if the transmission operation 303 is used; inasmuch
as this could include at one level the transmission of data from
the patient skin through the conductors 108, 109 and/or 110 through
the traces 107 to the electronics 103 for analysis there. In other
examples, of course, the transmission may include off-board
downloading to other computing resources (e.g., FIG. 4). In some
cases, such off-loading of the data may allow or provide for more
sophisticated analysis using higher computing power resources.
[0039] Further alternatives primarily may involve data storage,
both when and where, if used. As with intelligence, it may be that
either some or no storage or memory may be made available in/by the
electronics 103 on-board device 100. If some storage, whether a
little or a lot, is made available on device 100, then, flow path
312a to and through path 312c may be used to achieve some storing
of data 305. This may in many cases then, though not necessarily be
before transmission or analysis (note, for some types of data
multiple paths may be taken simultaneously, in parallel though
perhaps not at the same time or serially (eg., paths 312b and 312c
need not be taken totally to the exclusion of the other), so that
storage and transmission or storage and analysis may occur without
necessarily requiring a completion of any particular operation
before beginning or otherwise implementing another). Thus, after
(or during) storage 305, flow path 315a may be followed for stored
data which may then be transmitted, by path 315b to operation 303,
and/or analyzed, by path 315c to operation 304. In such a storage
example, which in many cases may also be an on-board storage
example, data can be collected then stored in local memory and
later off-loaded/transmitted to one or more robust computing
resources (e.g., FIG. 4) for analysis. Frequently, this can include
long term data collection, e.g., in the manner of days or weeks or
even longer, and may thus include remote collection when a patient
is away from a doctor's office or other medical facilities. Thus,
data can be collected from the patient in the patient's real world
circumstances. Then, after collection, the data can be transmitted
from its storage on device 100 back to the desired computing
resource (FIG. 4, e.g.), and such transmission might be wireless or
wired or come combination of both, as for example a blue tooth or
WiFi connection to a personal computer (FIG. 4 for one example)
which might then communicate the data over the internet to the
designated computer for final analysis. Another example might
include a USB connection to a computer, either to a PC or a
mainframe (FIG. 4), and may be to the patient computer or to the
doctor computer for analysis.
[0040] If little or no storage or memory is resident on device 100
(or in some examples even where there may be a large amount of
resident memory available), then, relatively soon after collection,
the data would need to or otherwise might desirably either or both
be transmitted and then stored, see path 313a after operation 303,
and/or transmitted and analyzed, paths 312 and 313. If path 313a is
used, then, more typically, the data storage may be in/on computing
resources (not shown in FIG. 3, but see FIG. 4 described below)
off-board (though on-board memory could be used as well), and then,
any of paths 315a, 315b and 315c may be used.
[0041] A feature hereof may include an overall system including one
or more devices 100 and computing resources (see FIG. 4, for
example) whether on-board device(s) 100, or separate, as for
example in personal or mobile or hand-held computing devices
(generally by FIG. 4), the overall system then providing the
ability for the physician or doctor to have immediate, in-office
analysis and presentation of collected test data. This would in
some implementations allow for on-site data analysis from the
device without utilization of a third party for data extraction and
analysis.
[0042] Alternative implementations hereof may thus include one or
more hardware and software combinations for multiple alternative
data source interpretations. As noted above, a device 100 hereof
includes hardware that monitors one or more of various physiologic
parameters, then generates and stores the associated data
representative of the monitored parameters. Then, a system which
includes hardware such as device 100 and/or the parts thereof, and
software and computing resources (FIG. 4, generally) for the
processing thereof. The system then includes not only the
collection of data but also interpretation and correlation of the
data.
[0043] For example, an electrocardiogram trace that reveals a
ventricular arrhythmia during intense exercise may be interpreted
differently than the same arrhythmia during a period of rest. Blood
oxygen saturation levels that vary greatly with movement can
indicate conditions that may be more serious than when at rest,
inter alia. Many more combinations of the four physiologic
parameters are possible, and the ability of software hereof to
display and highlight possible problems will greatly aid the
physician in diagnosis. Thus, a system as described hereof can
provide beneficial data interpretation.
[0044] Some of the features which can assist toward this end may be
subsumed within one or more of operations 303 and 304 of FIG. 3,
wherein data collected on a device 100 can rather simply be
communicated/transmitted to computing resources (again, whether
on-board device 100 or discrete therefrom as e.g., FIG. 4). For an
example, when a patient having had a device applied (operation 301)
may return to a physician's office after a test period wherein data
was collected (operation 302) the device is connected via one or
more data transmission alternatives, as for example, USB to a
computer (Windows or Mac) (generally with reference to FIG. 4 and
description thereof) in the office, allowing immediate analysis by
the physician while the patient waits (note, the device 100 may
first have been removed from the patient or might remain thereon
pending transmission and analysis for determination of whether more
data may be desired). In some implementations, data analysis time
may be relatively quick, at approximately 15 minutes in some
implementations, and might be achieved with a user-friendly GUI
(Graphic User Interface) to guide the physician through the
analysis software.
[0045] The analysis/software package may be disposed to present the
physician with results in a variety of formats. In some
implementations, an overview of the test results may be presented,
either together with or in lieu of more detailed results. In either
case, a summary of detected anomalies and/or patient-triggered
events may be provided, either as part of an overview and/or as
part of the more detailed presentation. Selecting individual
anomalies or patient-triggered events may provide desirable
flexibility to allow a physician to view additional detail,
including raw data from the ECG and/or from other sensors. The
package may also allow data to be printed and saved with
annotations in industry-standard EHR formats.
[0046] In one implementation, patient data may be analyzed with
software having the one or more of the following specifications.
Some alternative capabilities may include: 1. Data Acquisition;
i.e., loading of data files from device; 2. Data Formatting; i.e.,
formatting raw data to industry standard file formats (whether,
e.g., aECG (xml); DICOM; or SCP-ECG) (note, such data formatting
may be a part of Acquisition, Storage or Analysis, or may have
translation from one to another (e.g., data might be better stored
in a compact format that may need translation or other un-packing
to analyze)); 3. Data Storage (whether local, at a clinic/medical
facility level or e.g., in the Cloud (optional and allows offline
portable browser based presentation/analysis); 4. Analysis which
inter alia, may include, e.g., noise filtering (High pass/Low pass
digital filtering); and/or QRS (Beat) detection (in some cases, may
include Continuous Wave Transform (CWT) for speed and accuracy);
and/or 5. Data/Results Presentation, whether including one or more
graphical user interface(s) (GUIs) perhaps more particularly with
an overall Summary and/or General Statistics and/or Anomaly Summary
of Patient triggered event(s); presentation of additional levels of
detail whether of Strip view(s) of anomaly data by incident
(previous, next) Blood Oxygen saturation, stress correlation or the
like; and/or allowing care provider bookmarking/annotations/notes
by incident and/or Print capability.
[0047] Further, on alternative combinations of hardware with
proprietary software packages: I) One on-device software package
may be adapted to store the measurements from the data signals
acquired from one or more of EKG/ECG (whether right leg and/or p-,
qrs- and/or t-waves), or O2 saturation, or xyz acceleration, in a
time concordant manner, so that a physician may access a temporal
history of the measurements (say, in some examples, over a 1-2 week
interval), which would provide useful information on what the
patient's activity level was prior to, during, and after the
occurrence of a cardiac event. ii) an alternative to alternately
manage the real-time transmission of the real-time measured
parameters to a nearby station or relay. And/or; iii) an off-device
ECG analysis software aimed at recognizing arrhythmias.
[0048] The software mentioned above may be industry understood
software provided by a 3rd party, or specially adapted for the data
developed and transmitted by and/or received from a wearable device
100 hereof. Thorough testing using standard (MIT-BIH/AHA/NST)
arrhythmia databases, FDA 510(k) approvals preferred. Such software
may be adapted to allow one or more of automated ECG analysis and
interpretation by providing callable functions for ECG signal
processing, QRS detection and measurement, QRS feature extraction,
classification of normal and ventricular ectopic beats, heart rate
measurement, measurement of PR and QT intervals, and rhythm
interpretation.
[0049] In many implementations, the software may be adapted to
provide and/or may be made capable of supplying one or more of the
following measurements: [0050] 1. Heart Rate Min, Max and Average
[0051] 2. QRS duration average [0052] 3. PR interval average [0053]
4. QT interval average [0054] 5. ST deviation average and, may be
adapted to recognize a broad range of arrhythmias such as those set
forth here: [0055] 1. SINUS RHYTHM [0056] 2. SINUS RHYTHM+IVCD
[0057] 3. SINUS BRADYCARDIA [0058] 4. SINUS BRADYCARDIA+IVCD [0059]
5. SINUS TACHYCARDIA [0060] 6. PAUSE [0061] 7. UNCLASSIFIED RHYTHM
[0062] 8. ARTIFACT
[0063] This first group of 8 given above are arrhythmia types that
may be recognizable even if there is no discernible P wave. They
are the ones typically recognized by existing products in the
outpatient monitoring market that we propose to address.
[0064] A second set or group of arrhythmias; below, may require a
discernible and measurable P wave. Some implementations hereof may
be adapted to be able to detect and recognize them, as device 100
may be able as described above to detect P waves, depending of
course, and for example, on whether the strength of the P wave is
affected by device 100 placement or patient physiology. [0065] 9.
ATRIAL FIBRILLATION/FLUTTER SVR (slow) [0066] 10. ATRIAL
FIBRILLATION/FLUTTER CVR (normal rate) [0067] 11. ATRIAL
FIBRILLATION/FLUTTER RVR (rapid [0068] 12. FIRST DEGREE AV
BLOCK+SINUS RHYTHM [0069] 13. FIRST DEGREE AV BLOCK+SINUS
TACHYCARDIA [0070] 14. FIRST DEGREE AV BLOCK+SINUS BRADYCARDIA
[0071] 15. SECOND DEGREE AV BLOCK [0072] 16. THIRD DEGREE AV BLOCK
[0073] 17. PREMATURE ATRIAL CONTRACTION [0074] 18. SUPRAVENTRICULAR
TACHYCARDIA [0075] 19. PREMATURE VENTRICULAR CONTRACTION [0076] 20.
VENTRICULAR COUPLET [0077] 21. VENTRICULAR BIGEMINY [0078] 22.
VENTRICULAR TRIGEMINY [0079] 23. IDIOVENTRICULAR RHYTHM [0080] 24.
VENTRICULAR TACHYCARDIA [0081] 25. SLOW VENTRICULAR TACHYCARDIA
[0082] Further in alternative software implementations; some sample
screenshots are shown in FIG. 5. A first such alternative is shown
in FIG. 5A, which is an example screenshot showing ECG and Oxygen
Saturation data taken by using a patch device such as a device 100
hereof. An extremely clean signal is shown (no filtering or
smoothing has been done on this data). Distinct p-waves are also
shown (3 of which are shown as an example with arrows). P wave
detection can be extremely important for ECG anomaly detection.
Oxygen Saturation, as measured by Pulse Oxymetry, is shown on the
bottom plot. This is data taken by the a device on the chest, and
is taken in time concordance with the ECG data.
[0083] Another alternative is shown in FIG. 5B, which is an example
screenshot of Analysis Software. This is a sample of ECG data taken
from the MIT-BIH Arrhythmia Database, Record 205. As analyzed by
the Analysis system hereof, we see in the Event Occurrences Summary
list (top, left) five (5) anomaly types (plus normal sinus rhythm).
This list also shows the number of occurrences of each anomaly,
total duration of the anomaly in the complete ECG, and the percent
time this anomaly occurs in the complete ECG. To view specific
instances of each anomaly, the user double clicks the specific row
in the Event Occurrences Summary list, as shown in FIG. 5C.
[0084] As introduced, FIG. 5C is an example screenshot showing
specific instance of Ventricular Tachycardia. The ECG plot
automatically navigates to the specific time in the ECG waveform,
and marks the beginning and end of the event. More detailed data
about this specific event is now shown in the Occurrence Details:
HR Average, HR Max, etc. for the duration of this event. To show
the instances of another anomaly in this ECT, the user can click on
the Premature Ventricular Contraction (PVC) row of the Event
Occurrences Summary, as shown FIG. 5D.
[0085] As introduced, FIG. 5D is an example screenshot showing
specific instance of Premature Ventricular Contraction. This shows
occurrences of the PVC. The Start Times list (middle top) shows all
instances of PVC occurrences in this ECG, and lists the start time
for each occurrence. In this case, the user can click on the PVC
that starts at 00:15:27 (the 11.sup.th occurrence). The ECG plot is
automatically taken to this point in time to show and indicate the
PVC instances in the waveform. Since there are 3 instances of a PVC
in this timeslot, all 3 occurrences are marked.
[0086] Some further alternatives may include data transmission
and/or interpretation by local medical facilities, whether
physician or doctor offices or e.g., ICU/CCU (Intensive
Care/Coronary Care Units). Accordingly, a device 100 hereof that
will measure one or more of a variety of physiologic signals,
possibly including electrocardiogram, photoplethysmogram, pulse
oximetry and/or patient acceleration signals will be placed on the
patient's chest and held with an adhesive as described herein. The
device transmits the physiologic signals wirelessly or by wire
(e.g., USB) to a nearby base station for interpretation and further
transmission, if desired. The wireless transmission may use
Bluetooth, WiFi, Infrared, RFID (Radio Frequency IDentification) or
another wireless protocol. The device may be powered by wireless
induction, battery, or a combination of the two. The device 100
monitors physiological signals and/or collects data representative
thereof. The collected data may then be transmitted wirelessly or
by wire connection, in real time, to the nearby base station. The
device may be wirelessly powered by the base station or by battery,
removing the need for wires between the patient and the
station.
[0087] Thus, some of the alternative combinations hereof may
include one or more of: 1) medical grade adhesives (from many
possible sources) selected for their ability to maintain in
intimate contact with the skin without damaging it, for several
days (up to, say 10 days or two weeks in some examples), as well as
operability with different types of sensors; 2) conductive
electrodes or photo-sensitive detectors able to supply electrical
signals from the skin or from the photo-response of cutaneous or
subcutaneous tissues to photo-excitation; 3) amplifiers,
microprocessors and memories, capable of treating these signals and
storing them; 4) power supply for the electronics hereof with
stored or with wirelessly accessible re-chargeability; 5) flex
circuits capable of tying the above elements together within a
flexible strip capable of conforming to a cutaneous region of
interest.
[0088] Examples of physiological parameters that may be subject to
monitoring, recordation/collection and/or analyzing may include one
or more of: electrocardiograms, photo responses of photo-excited
tissues for e.g., oxygen saturation of blood; pulse rates and
associated fluctuations; indications of physical
activity/acceleration. One or more of these may be used in
monitoring ambulatory cardiac outpatients over several days and
nights, which could thereby provide for recording, for post-test
analysis, several days' worth of continuous ECG signals together
with simultaneous recording of O2 saturation and an index of
physical exertion. Similarly, one or more of these may be used in
monitoring ambulatory pulmonary outpatients over several days and
nights for recording, for post-test analysis, O2 saturation
together with simultaneous recording of an index of physical
activity. Alternatively and/or additionally, one or more of these
could be used for monitoring in-patients or other patients of
interest, as for example neonatals, wirelessly (or in some cases
wired), whether in clinics, emergency rooms, or ICUs, in some
instances detecting the parameters of EKG, O2 and/or physical
exertion, but instead of storing them would transmit them
wirelessly to either a bedside monitor or a central station
monitor, thus freeing the patient from attachment to physical
wires.
[0089] An exemplary computer system or computing resources which
may be used herewith will now be described, though it should be
noted that many alternatives in computing systems and resources may
be available and operable within the reasonably foreseeable scope
hereof so that the following is intended in no way to be limiting
of the myriad possible computational alternatives properly intended
within both the spirit and scope hereof.
[0090] Some of the implementations of the present invention include
various steps. A variety of these steps may be performed by
hardware components or may be embodied in machine-executable
instructions, which may be used to cause a general-purpose or
special-purpose processor programmed with the instructions to
perform the steps. Alternatively, the steps may be performed by a
combination of hardware, software, and/or firmware. As such, FIG. 4
is an example of computing resources or a computer system 400 with
which implementations hereof may be utilized. According to the
present example, a sample such computer system 400 may include a
bus 401, at least one processor 402, at least one communication
port 403, a main memory 404, a removable storage media 405, a read
only memory 406, and a mass storage 407. More or fewer of these
elements may be used in a particular implementation hereof.
[0091] Processor(s) 402 can be any known processor, such as, but
not limited to, an Intel.RTM. Itanium.RTM. or Itanium 2.RTM.
processor(s), or AMD.RTM. Opteron.RTM. or Athlon MP.RTM.
processor(s), or Motorola.RTM. lines of processors. Communication
port(s) 403 can be any of an RS-232 port for use with a modem based
dialup connection, a 10/100 Ethernet port, a Universal Serial Bus
(USB) port, or a Gigabit port using copper or fiber. Communication
port(s) 403 may be chosen depending on a network such a Local Area
Network (LAN), Wide Area Network (WAN), or any network to which the
computer system 400 connects or may be adapted to connect.
[0092] Main memory 404 can be Random Access Memory (RAM), or any
other dynamic storage device(s) commonly known in the art. Read
only memory 406 can be any static storage device(s) such as
Programmable Read Only Memory (PROM) chips for storing static
information such as instructions for processor 402.
[0093] Mass storage 407 can be used to store information and
instructions. For example, hard disks such as the Adaptec.RTM.
family of SCSI drives, an optical disc, an array of disks such as
RAID, such as the Adaptec family of RAID drives, or any other mass
storage devices may be used.
[0094] Bus 401 communicatively couples processor(s) 402 with the
other memory, storage and communication blocks. Bus 401 can be a
PCI/PCI-X or SCSI based system bus depending on the storage devices
used.
[0095] Removable storage media 405 can be any kind of external
hard-drives, floppy drives, IOMEGA.RTM. Zip Drives, Compact
Disc-Read Only Memory (CD-ROM), Compact Disc-Re-Writable (CD-RW),
Digital Video Dis-Read Only Memory (DVD-ROM).
[0096] The components described above are meant to exemplify some
types of possibilities. In no way should the aforementioned
examples limit the scope of the invention, as they are only
exemplary embodiments.
[0097] Embodiments of the present invention relate to devices,
systems, methods, media, and arrangements for monitoring and
processing cardiac parameters and data, inter alia. While detailed
descriptions of one or more embodiments of the invention have been
given above, various alternatives, modifications, and equivalents
will be apparent to those skilled in the art without varying from
the spirit of the invention. Therefore, the above description
should not be taken as limiting the scope of the invention, which
is defined by the appended claims.
* * * * *